{"id":29889,"date":"2024-11-29T01:48:39","date_gmt":"2024-11-29T01:48:39","guid":{"rendered":"https:\/\/www.ikonixasia.com\/?p=29889"},"modified":"2024-12-16T04:01:43","modified_gmt":"2024-12-16T04:01:43","slug":"issue59-simplifying-medical-device-testing-solutions-you-need-to-know","status":"publish","type":"post","link":"https:\/\/www.ikonixasia.com\/tw\/2024\/11\/issue59-simplifying-medical-device-testing-solutions-you-need-to-know\/","title":{"rendered":"\u91ab\u7642\u8a2d\u5099\u6e2c\u8a66\u8f15\u9b06\u5316\uff1a\u5e38\u898b\u554f\u984c\u8207\u89e3\u6c7a\u65b9\u6848"},"content":{"rendered":"
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\n\t

\u53f0\u7063\u91ab\u7642\u79d1\u6280\u5c55\u5373\u5c07\u767b\u5834\uff0c\u8a31\u591a\u570b\u969b\u5927\u5ee0\u63a8\u51fa\u65b0\u7522\u54c1\u3002\u6216\u8a31\u9019\u4e9b\u5546\u54c1\u4f60\u76ee\u524d\u90fd\u9084\u662f\u964c\u751f\uff0c\u4f46\u5728\u91ab\u9662\u5c31\u8a3a\u6642\uff0c\u6211\u5011\u90fd\u66fe\u4f7f\u7528\u904e\u91ab\u7642\u5100\u5668\u3002\u4f60\u662f\u5426\u66fe\u7d93\u597d\u5947\uff0c\u70ba\u4ec0\u9ebc\u6211\u5011\u5c0d\u9019\u4e9b\u8a2d\u5099\u5982\u6b64\u4fe1\u4efb\uff0c\u653e\u5fc3\u8b93\u5b83\u5011\u63a5\u89f8\u6211\u5011\u7684\u8eab\u9ad4\uff1f\u5728\u91ab\u7642\u7522\u696d\u4e2d\uff0c\u9019\u4e9b\u8a2d\u5099\u5c0d\u65bc\u4fdd\u969c\u60a3\u8005\u8207\u91ab\u8b77\u4eba\u54e1\u7684\u5b89\u5168\u81f3\u95dc\u91cd\u8981\u3002\u7136\u800c\uff0c\u4e00\u65e6\u8a2d\u5099\u767c\u751f\u6545\u969c\uff0c\u53ef\u80fd\u5c0e\u81f4\u60a3\u8005\u53d7\u50b7\u3001\u8a2d\u5099\u640d\u58de\uff0c\u751a\u81f3\u5ef6\u8aa4\u6cbb\u7642\u6642\u6a5f\u3002<\/p>\n

\u70ba\u907f\u514d\u9019\u4e9b\u98a8\u96aa\uff0c\u91ab\u7642\u8a2d\u5099\u88fd\u9020\u5546\u5fc5\u9808\u7b26\u5408\u56b4\u683c\u7684\u5b89\u5168\u6a19\u6e96\uff0c\u4f8b\u5982\u5168\u7403\u91ab\u7642\u8a2d\u5099\u5b89\u5168\u57fa\u6e96 IEC 60601\u3002\u5728 Associated Research\uff0c\u6211\u5011\u63d0\u4f9b\u53ef\u9760\u7684\u89e3\u6c7a\u65b9\u6848\uff0c\u5e6b\u52a9\u88fd\u9020\u5546\u6709\u6548\u5730\u6e2c\u8a66\u4ed6\u5011\u7684\u7522\u54c1\u3002\u5728\u672c\u6587\u4e2d\uff0c\u6211\u5011\u5c07\u63a2\u8a0e\u88fd\u9020\u5546\u9762\u81e8\u7684\u6311\u6230\uff0c\u4ee5\u53ca\u6211\u5011\u7684\u89e3\u6c7a\u65b9\u6cd5\u3002<\/p>\n

\u91ab\u7642\u8a2d\u5099\u7684\u5e38\u898b\u6e2c\u8a66<\/strong><\/h3>\n

\u5728\u6211\u5011\u7684\u5148\u524d\u96fb\u5b50\u5831\u548c\u91ab\u7642\u96fb\u5b50\u8a2d\u5099\u7522\u696d\u61c9\u7528\u66f8\u4e2d\uff0c\u6211\u5011\u5206\u4eab\u4e86\u8a31\u591a\u6e2c\u8a66\u7684\u898b\u89e3\u3002\u70ba\u7b26\u5408 IEC 60601<\/strong> \u6a19\u6e96\uff0c\u91ab\u7642\u8a2d\u5099\u9700\u901a\u904e\u6578\u9805\u91cd\u8981\u6e2c\u8a66\uff0c\u4ee5\u4e0b\u70ba\u6700\u5e38\u898b\u7684\u6e2c\u8a66\u985e\u578b\uff1a<\/p>\n

    \n
  1. \u4ea4\u6d41\u8010\u58d3\u6e2c\u8a66 (AC Hipot Tests)\uff1a\u8a55\u4f30\u8f38\u5165\u96fb\u6e90\u53ca\u61c9\u7528\u90e8\u5206\u7684\u7d55\u7de3\u5f37\u5ea6\u3002<\/li>\n
  2. \u63a5\u5730\u9023\u63a5\u6e2c\u8a66 (Ground Bond Tests)\uff1a\u78ba\u4fdd\u63a5\u5730\u9023\u63a5\u80fd\u627f\u53d7 25 \u81f3 40 \u5b89\u57f9\u7684\u6545\u969c\u96fb\u6d41\u3002\u4fdd\u8b77\u63a5\u5730\u8207\u4efb\u4f55\u63a5\u5730\u90e8\u4ef6\u4e4b\u9593\u7684\u963b\u6297\u8981\u4f4e\u65bc1\u03a9\u3002<\/li>\n
  3. \u7d55\u7de3\u96fb\u963b\u6e2c\u8a66 (Insulation Resistance Tests)\uff1a\u78ba\u8a8d\u7d55\u7de3\u5c64\u5167\u6c92\u6709\u975e\u9810\u671f\u7684\u96fb\u6d41\u6d41\u52d5\u3002<\/li>\n
  4. \u6f0f\u96fb\u6d41\u6e2c\u8a66 (Leakage Current Tests)\uff1a\u6e2c\u91cf\u5728\u63a5\u5730\u6f0f\u96fb\u6d41 (Earth Leakage)\u3001\u63a5\u89f8\u96fb\u6d41 (Enclosure Leakage\/ Touch Current)\u3001\u60a3\u8005\u6f0f\u96fb\u6d41 (Patient Leakage)\u3001\u60a3\u8005\u8f14\u52a9\u96fb\u6d41 (Patient Auxiliary Leakage) \u548c\u81ea\u5e36\u96fb\u61c9\u7528\u90e8\u4ef6\u6f0f\u96fb\u6d41 (Mains on Applied Part Leakage)\u3002\u61c9\u7528\u90e8\u4ef6\u662f\u6307\u8207\u75c5\u60a3\u76f4\u63a5\u63a5\u89f8\u7684\u91ab\u7642\u5668\u6750\uff0c\u53c8\u5206\u70ba\u4e09\u985e\uff1aType B \u96fb\u6d41\u6c92\u6709\u8207\u75c5\u60a3\u76f4\u63a5\u63a5\u89f8\u3001Type BF \u96fb\u6d41\u6709\u8207\u75c5\u60a3\u76f4\u63a5\u63a5\u89f8\u4f46\u6c92\u901a\u904e\u5fc3\u81df\u8207Type CF \u96fb\u6d41\u6703\u901a\u904e\u75c5\u60a3\u7684\u5fc3\u81df\u3002<\/li>\n<\/ol>\n

    \u9019\u4e9b\u6e2c\u8a66\u96d6\u7136\u91cd\u8981\uff0c\u4f46\u88fd\u9020\u5546\u5728\u78ba\u4fdd\u5408\u898f\u7684\u904e\u7a0b\u4e2d\u5f80\u5f80\u9762\u81e8\u66f4\u591a\u6311\u6230\u3002<\/p>\n

    \u91ab\u7642\u8a2d\u5099\u6e2c\u8a66\u7684\u4e09\u5927\u6311\u6230\u8207\u89e3\u6c7a\u65b9\u6848<\/strong><\/h3>\n
      \n
    1. \n

      \u6e2c\u8a66\u8017\u6642\u904e\u9577<\/strong><\/h4>\n<\/li>\n<\/ol>\n

      \u6311\u6230<\/strong>\uff1a\u591a\u9805\u6e2c\u8a66\u4f7f\u751f\u7522\u7dda\u6548\u7387\u964d\u4f4e\u3002
      \n\u89e3\u6c7a\u65b9\u6848<\/strong>\uff1a
      \nOMNIA\u00ae II <\/strong>\u7cfb\u5217<\/strong>\u5c07\u4e03\u9805\u95dc\u9375\u6e2c\u8a66\u6574\u5408\u81f3\u4e00\u53f0\u8a2d\u5099\uff0c\u5305\u62ec\u8010\u58d3\u3001\u7d55\u7de3\u96fb\u963b\u3001\u63a5\u5730\u9023\u63a5\u53ca\u6f0f\u96fb\u6d41\u6e2c\u8a66\u3002\u5167\u5efa 500VA \u96fb\u6e90\uff0c\u80fd\u8655\u7406\u9ad8\u529f\u7387\u8a2d\u5099\uff0c\u5927\u5e45\u6e1b\u5c11\u6e2c\u8a66\u6642\u9593\u8207\u6210\u672c\u3002\u5c0d\u65bc\u9700\u66f4\u5927\u529f\u7387\u7684\u8a2d\u5099\uff0ceec 8500 <\/strong>\u7cfb\u5217\u4ea4\u6d41\u96fb\u6e90<\/strong>\u5247\u63d0\u4f9b\u7a69\u5b9a\u8f38\u51fa\uff0c\u6700\u5927\u5bb9\u91cf\u9054 6kVA\uff0c\u6eff\u8db3\u9ad8\u529f\u7387\u9700\u6c42\u3002<\/p>\n

        \n
      1. \n

        \u64cd\u4f5c\u932f\u8aa4\u983b\u7e41<\/strong><\/h4>\n<\/li>\n<\/ol>\n

        \u6311\u6230<\/strong>\uff1a\u8907\u96dc\u7684\u6e2c\u8a66\u8a2d\u7f6e\u8207\u983b\u7e41\u7684\u9023\u63a5\u5207\u63db\u5bb9\u6613\u5c0e\u81f4\u932f\u8aa4\u3002
        \n\u89e3\u6c7a\u65b9\u6848<\/strong>\uff1a
        \nSC6540 <\/strong>\u6e2c\u8a66\u6383\u63cf\u5668<\/strong>\u7c21\u5316\u4e86\u591a\u9ede\u548c\u6279\u91cf\u6e2c\u8a66\u6d41\u7a0b\uff0c\u6e1b\u5c11\u932f\u8aa4\u767c\u751f\u4e26\u63d0\u5347\u8a2d\u7f6e\u6548\u7387\uff0c\u78ba\u4fdd\u6e2c\u8a66\u7d50\u679c\u66f4\u6e96\u78ba\u3002<\/p>\n

          \n
        1. \n

          \u6e2c\u8a66\u6578\u64da\u7ba1\u7406\u56f0\u96e3<\/strong><\/h4>\n<\/li>\n<\/ol>\n

          \u6311\u6230<\/strong>\uff1a\u8a18\u9304\u6e2c\u8a66\u7d50\u679c\u4ee5\u5efa\u7acb\u8a2d\u5099\u6b77\u53f2\u8a18\u9304\u662f\u4e00\u9805\u7e41\u7463\u7684\u5de5\u4f5c\u3002
          \n\u89e3\u6c7a\u65b9\u6848<\/strong>\uff1a
          \nWithStand\u00ae <\/strong>\u8edf\u9ad4<\/strong>\u53ef\u81ea\u52d5\u751f\u6210\u8a73\u7d30\u7684\u8ffd\u6eaf\u5831\u544a\uff0c\u6355\u6349\u5305\u62ec\u901a\u904e\/\u5931\u6557\u7d50\u679c\u3001\u578b\u865f\u548c\u5e8f\u5217\u865f\u7b49\u95dc\u9375\u6578\u64da\uff0c\u7c21\u5316\u6587\u4ef6\u7ba1\u7406\u4e26\u63d0\u9ad8\u53ef\u8ffd\u6eaf\u6027\u3002<\/p>\n

           <\/p>\n

          \u6e1b\u8f15\u6e2c\u8a66\u8ca0\u64d4\uff0c\u73fe\u5728\u5c31\u884c\u52d5\uff01<\/strong><\/h3>\n

          Associated Research \u63d0\u4f9b\u5168\u65b9\u4f4d\u91ab\u7642\u6e2c\u8a66\u89e3\u6c7a\u65b9\u6848\u2014\u2014MedTEST \u7cfb\u7d71\uff0c\u5c08\u70ba\u514b\u670d\u91ab\u7642\u5668\u6750\u88fd\u9020\u904e\u7a0b\u4e2d\u7684\u5404\u7a2e\u6311\u6230\u800c\u8a2d\u8a08\u3002\u5982\u679c\u60a8\u662f\u91ab\u7642\u5668\u6750\u88fd\u9020\u5546\uff0c\u4e26\u6b63\u9762\u81e8\u4ee5\u4e0a\u554f\u984c\uff0c\u8acb\u7acb\u5373\u8207\u6211\u5011\u806f\u7e6b\uff01\u6211\u5011\u5c07\u70ba\u60a8\u63d0\u4f9b\u5c08\u696d\u5efa\u8b70\u8207\u9ad8\u6548\u89e3\u6c7a\u65b9\u6848\uff0c\u5354\u52a9\u60a8\u512a\u5316\u6e2c\u8a66\u6d41\u7a0b\uff0c\u63d0\u5347\u751f\u7522\u6548\u7387\u8207\u7522\u54c1\u53ef\u9760\u6027\uff01<\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"

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